What is it? Regression Testing is an important element of software maintenance and is critical to ensuring your lab software remains compliant through any change process, like updates, upgrades, or add-ons of additional modules.

What does it do? Regression Testing challenges the system’s ability to still do what it should after being modified according to specified requirements, and portions of the software not involved in the change were not adversely affected.

Why do I need it? The basic underlying reason for testing a computerized system or application is to provide a documented high level of assurance that the system is fit for its intended use prior to the system being used in the live environment, not only initially but any time a change is made to the system. Even seemingly insignificant changes in software code can create unexpected and very significant problems elsewhere in the application. The software development process should include testing, and the testing approach should reflect risks to product quality, patient safety, and data integrity.

Testing is a fundamental requirement of current best practices regarding achieving and maintaining regulatory compliance. Although the need to test computerized systems is defined by certain regulatory guidance (Section 5 of the FDA’s "Guidance Principles of Software Validation: Final Guidance for Industry and FDA Staff”) the way in which computer systems would be tested is not defined in detail. The regulatory expectations are based on the principle that computer systems are tested in order to confirm that user and functional requirements have been met and in order to assure data integrity by providing a defined method of testing changes, fixes and new functionality. These, in turn, are driven by a need to assure patient safety. This is particularly true when changes are made during various intervals of system testing.

Planning Your Testing Project

Several things need to be considered when planning your testing project:

• What should be tested?
• How much testing is enough?
• How should testing be conducted? (e.g. manual or automated)
• How should the testing be documented?
• What type of environment is best for testing?
• How do we record test results for review?
• Who is responsible for which tasks?
• Do we need to create specific testing policies?
• And so much more!

Daunting? Yes! But HELP IS AVAILABLE!

For over 25 years, BC Solutions consultants have helped clients of all sizes manage their projects to success. Contact us to learn more or to talk about your project! We are ready to help!

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